Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients

Hypothermia Clinical Trial

— THERMOTRAUMA  

Official title:

Evaluation of Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients During Pre-hospital Medical Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970915
• Other study ID #: 69HCL19_0033
• Secondary ID: 2019-A01163-54
• Status: Completed
• Phase: N/A
• Start date: October 17, 2019
• Est. completion date: April 27, 2022

Study information

• Verified date: May 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of adult patients with severe all-cause trauma having a body temperature less than 36°Celsius (C) that is managed by a Mobile Emergency Service team and oriented towards a Vital Emergency Room. Currently two devices are used to warm patients during their care at the scene of an accident: a survival blanket and heating in the emergency vehicle. Despite these two devices many patients arrive in hypothermia (body temperature less than 36°C) in emergency departments. The objective of this study is to evaluate the effectiveness of a body warmer associated with standard warming devices on the correction of hypothermia compared to the standard procedure in severely traumatized patients with hypothermia . It is a national multicentric study with 14 participating Mobile Emergency Service centers and hopefully will include 612 patients. The study will be carried out according to a pattern of 28 successive periods of one week each during the winter period (October to April), for a total duration of 7 months. 14 action periods ON (warming standard procedure + body warmer) and 14 control periods OFF (warming standard procedure) will be run in random order for each center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major patient with all-cause trauma Grade A or B
• Patient with a trans-tympanic body temperature of less than 36°Celsius (C) at primary management by terrestrial or heliport Mobile Emergency Service team.

Exclusion Criteria:

• Patient initially supported by a pre-hospital medical team who does not participate in the study,
• Patient with cardiopulmonary arrest at initial pre-hospital medical team management,
• Patient with bilateral otorrhagia (due to the non-feasibility of trans tympanic temperature),
• Patient with inguinal crease or subclavicular fossa injury,
• Patient with severe burn (Burnt Body Surface> 20%),
• Patient deprived of liberty including patients with an electronic bracelet.

Related Conditions & MeSH terms

• Hypothermia
• Psychological Trauma
• Trauma, Psychological

Intervention

Device:
• Body warmer
The body warmer will be wrapped in a waterproof treatment field to avoid the risk of burns, 2 body warmer will be applied on the inguinal crease and 2 on the subclavicular fossa.
• Standard warming procedure
Warming only according to the standard procedure : survival blanket and heating in the emergency vehicle.

Locations

Country	Name	City	State
France	SAMU 69 - SMUR - Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency	Body temperature will be measured in trans-tympanic when the patient arrived in the Vital Emergency Room.	4 hours
Secondary	Change in body temperature between initial treatment by the Mobile Emergency Service team and arrival at Vital Emergency Room.	Body temperature will be measured in trans-tympanic every 15 minutes between initial treatment by the pre-hospital medical team and arrival at emergency room.	4 hours
Secondary	Proportion of patients with coagulopathy on arrival at the emergency room.	Coagulopathy refers to disorders of blood coagulation whether they are pathological thrombosis or haemorrhagic syndromes. The coagulopathy criteria appear early and their measurements are systematically carried on admission to the emergency room.	4 hours
Secondary	Proportion of patients with acidosis on arrival at the emergency room.	Acidosis is a disorder of the acid-base balance of the body corresponding to an increase in the concentration of acid in plasma and interstitial fluids. It can be metabolic or respiratory. In the case of a state of shock, lactic acid occurs in situations where the tissues of the body are poorly irrigated and lack oxygen.	4 hours
Secondary	Evaluation of mortality	Proportion of deaths at one month (72h after admission to emergency room).	72 hours
Secondary	Evaluation of mortality (deaths before admission )	Proportion of deaths before admission to emergency room.	72 hours
Secondary	Evaluation of mortality (cardio respiratory arrest)	Proportion of cardio respiratory arrest before admission to emergency room.	72 hours
Secondary	Loss of heat due to a drop of temperature		4 hours
Secondary	First degree burn		4 hours
Secondary	Patient feels cold		4 hours